Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer

Sponsor
Air Force Military Medical University, China
Study ID
NCT07569679
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HAIC — PROCEDURE
    HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
  • Gemcitabine plus Cisplatin — DRUG
    Gemcitabine and cisplatin administered intravenously according to institutional standard first-line regimens for biliary tract cancer. Dosing and schedule follow each center's standard treatment protocols.
  • Adebrelimab — DRUG
    Adebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.
  • Apatinib — DRUG
    Apatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.

Study Details

This prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line treatment. The study comprises two cohorts: one receiving alternating HAIC and systemic chemotherapy alongside adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment allocation follows real-world clinical decision-making. Patients will be monitored throughout the treatment period to assess tumor response, survival outcomes, and safety profiles. The study aims to generate evidence on the clinical benefits of integrating immunotherapy and targeted therapy into HAIC-based regimens for this patient population.

Key Dates

Start date
Dec 10, 2025
Status verified
Apr 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib
    Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin, combined with adebrelimab (1200 mg every 3 weeks) and apatinib (250 mg orally once daily). The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols.
  • Active Comparator: Alternating HAIC and Systemic Chemotherapy Alone
    Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin. The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: The maximum time from receiving treatment to dying for any reason is 3 years. ]

Central Contacts

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